An Open-label, Multiple-dose, Fixed-sequence, 3-Period Study to Evaluate the Pharmacokinetic Interactions and Safety in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- The Pharmacokinetics(PK) parameters AUCss,τ
研究概览
简要总结
To evaluate and compare the pharmacokinetic interactions and safety of multiple dose of Treatment A and Treatment B alone and in combination
详细描述
The objective of this study was to evaluate pharmacokinetic characteristics and safety after oral concurrent administration of Treatment A and Treatment B compared to each single administration in Healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers, aged between 19 to 45 years (both inclusive) at the screening.
- •Subjects who are informed of the investigational nature of this study, and voluntarily agree to participate in this study and signs informed consent
排除标准
- •Subjects who have a clinically significant past or present medical history of hepato-biliary, renal, gastrointestinal, respiratory, hematologic/neoplastic, endocrine, urologic, psychiatric, musculoskeletal, immunologic, Otorhinolaryngological, and cardiovascular diseases.
- •Subjects who have a medical history and/or condition that is considered to be dangerous to take the study drug.
研究组 & 干预措施
Period II
Subject will receive Drug(A), then take it by oral, once-daily form Day 14 to Day 23
干预措施: A (Drug)
Period III
Subject will receive Drug(LivaloVA), then take it by oral, once-daily form Day 24 to Day 30
干预措施: LivaloVA (Drug)
Period I
Subject will receive Drug(LivaloV), then take it by oral, once-daily form Day 1 to Day 7
干预措施: LivaloV (Drug)
结局指标
主要结局
The Pharmacokinetics(PK) parameters AUCss,τ
时间窗: 0~24 hours
AUCss,τ in a steady-state after multiple-dose (single or combined administration).
The Pharmacokinetics(PK) parameters Css,max
时间窗: 0~24 hours
Css,max in a steady-state after multiple-dose (single or combined administration).
次要结局
未报告次要终点